Protect And Prime Broad Spectrum Spf30 Cream
FDA Label NDC 70453-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Emma Hardie Ltd for the product Protect And Prime Broad Spectrum Spf30 (NDC 70453-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredients, purpose, use, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Avobenzone 3%

Octinoxate 7.5%

Octocrylene 10

Oxybenzone 6%

Purpose

Sunscreen

Use

  • Helps prevent sunburn

Warnings

For external use only

Do Not Use

on damaged or broken skin

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use And Ask A Doctor If

rash occurs

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply generously 15 minutes before sun exposure
  • Use a Water Resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses

Other Information

  • Protect the product in this container from excessive heat and direct sun

Inactive Ingredients

Water (Aqua), caprylic/capric triglyceride, Green Wattle (Acacia Decurrens)/Jojoba (Simmondsia Chinensis)/Sunflower (Helianthis Annus) Seed Wax/Polyglyceryl-3 Esters, HDI/Trimethylol Hexyllactone Crosspolymer, Tapioca Starch, Manketti (Schinziophyton Rautaneii) Kernel Oil, Shea Butter (Vitellaria Paradoxa), Stearic Acid, Glycerin, Butylene Glycol Stearate SE, Phenoxyethanol, Benzyl Alcohol, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Fragrance (Parfum), Polyhydroxystearic Acid, Geraniol, Limonene, Citronellol, Xanthan Gum, Linalool, Alumina, Aluminum Stearate, Disodium EDTA, Ethylhexylglycerin, Dehydroacetic Acid, Silica, Sodium Stearate, Polymethylsilsesquioxane, Disodium Rutinyl Disulfate, Barley (Hordeum Districhon) Extract, Lemon Balm (Melissa Officinalis) Leaf Extract, Sodium Benzoate, Citral, Citric Acid, Farnesol, Titanium Dioxide (CI 77891)

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